A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Pr… (NCT06202248) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer
Israel10 participantsStarted 2024-03-12
Plain-language summary
This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. Secondary objectives are to 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds.
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging \[Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.
Who can participate
Age range18 Years – 120 Years
SexMALE
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Inclusion Criteria:
* Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting
* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1
* Patient being considered for focal salvage brachytherapy
* Lesion size ≤ 3 cm in the longest diameter
* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds
* Pre-salvage PSA level (rPSA) below \<10 ng/ml
* Age ≥ 18 years old
* ECOG Performance Status Scale ≤ 2
* Subjects' life expectancy is more than 6 months
* Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0
* Platelet count ≥100,000/mm3
* Subjects are willing and able to sign an informed consent form.
Exclusion Criteria:
* N1 or M1 disease
* Prior TURP or prostate surgery
* Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)
* Inability to undergo general or spinal anesthesia
* Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0.
* Previous diagnosis of other malignancy \< 3 years of enrollment (excluding non-melanomatous skin cancer)
* Volunteers pa…
What they're measuring
1
Feasibility of intratumoral DaRT seeds implantation
Timeframe: immediately following the insertion procedure